FDA v. American College of Obstetricians and Gynecologists

Cite as: 592 U. S. ____ (2020) 1
ALITO, J., dissenting
SUPREME COURT OF THE UNITED STATES
_________________
No. 20A34
_________________
FOOD AND DRUG ADMINISTRATION, ET AL. v.
AMERICAN COLLEGE OF OBSTETRICIANS
AND GYNECOLOGISTS, ET AL.
ON APPLICATION FOR STAY
[October 8, 2020]
The Government seeks a stay of an injunction preventing
the Food and Drug Administration from enforcing in-person
dispensation requirements for the drug mifepristone during
the pendency of the public health emergency. The Govern-
ment argues that, at a minimum, the injunction is overly
broad in scope, given that it applies nationwide and for an
indefinite duration regardless of the improving conditions
in any individual State. Without indicating this Court’s
views on the merits of the District Court’s order or injunc-
tion, a more comprehensive record would aid this Court’s
review. The Court will therefore hold the Government’s ap-
plication in abeyance to permit the District Court to
promptly consider a motion by the Government to dissolve,
modify, or stay the injunction, including on the ground that
relevant circumstances have changed. See Febre v. United
States, 396 U.S. 1225, 1225–1226 (1969) (Harlan, J., in
chambers); see also Parr v. United States, 351 U.S. 513,
520 (1956). The District Court should rule within 40 days
of receiving the Government’s submission.
JUSTICE ALITO, with whom JUSTICE THOMAS joins,
dissenting.
The Government has filed an emergency application to
stay an injunction against enforcement of a longstanding
2 FDA v. AMERICAN COLLEGE OF OBSTETRICIANS AND
GYNECOLOGISTS
ALITO, J., dissenting
drug-safety rule issued by the Food and Drug Administra-
tion (FDA). Six weeks have passed since the application
was submitted, but the Court refuses to rule. Instead, it
defers any action until the Government moves in the Dis-
trict Court to modify the injunction and the District Court
rules on that motion, a process that may take another six
weeks or more.
There is no legally sound reason for this unusual disposi-
tion. The only justification even hinted by the Court is the
possibility that modification of the injunction may be re-
quired due to changes in the severity of the problems caused
by the COVID–19 pandemic, but that possibility does not
justify the Court’s refusal to rule. Indeed, for all practical
purposes, there is little difference between what the Court
has done and an express denial of the Government’s appli-
cation. In both situations, the FDA rule may not be en-
forced, and in both situations, the Government is able to
move the District Court to modify the injunction based on
changed circumstances. See Horne v. Flores, 557 U.S. 433,
447 (2009) (Federal Rule of Civil Procedure 60(b)(5) “pro-
vides a means by which a party can ask a court to modify or
vacate a judgment or order if ‘a significant change . . . in
factual conditions’ . . . renders continued enforcement ‘det-
rimental to the public interest’ ” (quoting Rufo v. Inmates of
Suffolk County Jail, 502 U.S. 367, 384 (1992))).
There is, however, one difference (but not a legally signif-
icant one) between what the Court has done and the express
denial of the Government’s application. Expressly denying
a stay would highlight the inconsistency in the Court’s rul-
ings on COVID–19-related public safety measures. In re-
sponse to the pandemic, state and local officials have im-
posed unprecedented restrictions on personal liberty,
including severe limitations on First Amendment rights.
Officials have drastically limited speech, banning or re-
stricting public speeches, lectures, meetings, and rallies.
Cite as: 592 U. S. ____ (2020) 3
ALITO, J., dissenting
The free exercise of religion also has suffered previously un-
imaginable restraints, and this Court has stood by while
that has occurred.
In South Bay United Pentecostal Church v. Newsom, 590
U. S. ___ (2020), this hands-off approach was defended on
the following ground:
“Our Constitution principally entrusts ‘the safety and
the health of the people’ to the politically accountable
officials of the States ‘to guard and protect.’ Jacobson
v. Massachusetts, 197 U.S. 11, 38 (1905). When those
officials ‘undertake to act in areas fraught with medical
and scientific uncertainties,’ their latitude ‘must be es-
pecially broad.’ Marshall v. United States, 414 U.S.
417, 427 (1974). Where those broad limits are not ex-
ceeded, they should not be subject to second-guessing
by an ‘unelected federal judiciary,’ which lacks the
background, competence, and expertise to assess public
health and is not accountable to the people. See Garcia
v. San Antonio Metropolitan Transit Authority, 469
U.S. 528, 545 (1985).” Id., at ___ (ROBERTS, C. J., con-
curring in denial of application for injunctive relief )
(slip op., at 2) (alterations omitted).
The extent of this deference was illustrated weeks later
when the Court deferred to the judgment of the Governor of
Nevada that attendance at worship services presented a
greater threat to public health than engaging in the diver-
sions offered by the State’s casinos. Calvary Chapel Dayton
Valley v. Sisolak, ante, p. ___. The possibility that this du-
bious conclusion might have been based less on science than
on the influence of the State’s powerful gaming industry
and its employees was not enough to move the Court. Near-
total deference was the rule of the day.
In the present case, however, the District Court took a
strikingly different approach. While COVID–19 has pro-
vided the ground for restrictions on First Amendment
4 FDA v. AMERICAN COLLEGE OF OBSTETRICIANS AND
GYNECOLOGISTS
ALITO, J., dissenting
rights, the District Court saw the pandemic as a ground for
expanding the abortion right recognized in Roe v. Wade, 410
U.S. 113 (1973). At issue is a requirement adopted by the
FDA for the purpose of protecting the health of women who
wish to obtain an abortion by ingesting certain medications,
specifically, mifepristone and misoprostol. Under that re-
quirement, a woman must receive a mifepristone tablet in
person at a hospital, clinic, or medical office. Electronic
Court Filing in No. 8:20–cv–01320, Doc. 1–4 (D Md., May
27, 2020), p. 3. The FDA first adopted the requirement in
2000, and then included it in a package of safety require-
ments under express statutory authority in 2007. See 21
U.S. C. §355–1(f )(3)(C). Over the course of four presiden-
tial administrations, the FDA has enforced this require-
ment and has not found it appropriate to remove it. During
the COVID–19 pandemic, the FDA suspended in-person
dispensing requirements for some drugs, but it evidently
decided that the mifepristone requirement should remain
in force.
Nevertheless, a District Court Judge in Maryland took it
upon himself to overrule the FDA on a question of drug
safety. Disregarding THE CHIEF JUSTICE’s admonition
against judicial second-guessing of officials with public
health responsibilities, the judge concluded that requiring
women seeking a medication abortion to pick up mifepris-
tone in person during the COVID–19 pandemic constitutes
an “undue burden” on the abortion right, and he therefore
issued a nationwide injunction against enforcement of the
FDA’s requirement. The judge apparently was not troubled
by the fact that those responsible for public health in Mar-
yland thought it safe for women (and men) to leave the
house and engage in numerous activities that present at
least as much risk as visiting a clinic—such as indoor res-
taurant dining, visiting hair salons and barber shops, all
sorts of retail establishments, gyms and other indoor exer-
cise facilities, nail salons, youth sports events, and, of
Cite as: 592 U. S. ____ (2020) 5
ALITO, J., dissenting
course, the State’s casinos.* And the judge made the in-
junction applicable throughout the country, including in lo-
cales with very low infection rates and limited COVID–19
restrictions.
Under the approach recently taken by the Court in cases
involving restrictions on First Amendment rights, the
proper disposition of the Government’s stay application
should be clear: grant. But the Court is not willing to do
that. Nor is it willing to deny the application. I see no rea-
son for refusing to rule.
This case presents important issues that richly merit re-
view. The District Court’s decision, if reviewed, is likely to
be reversed. And if the FDA is right in its assessment of
mifepristone, non-enforcement of the requirement risks ir-
reparable harm. A stay is amply warranted.
For these reasons, I respectfully dissent.
——————
* See, e.g., Governor Hogan Announces Next Stage Two Reopenings,
Including Indoor Dining and Outdoor Amusements (June 10, 2020),
https://governor.maryland.gov/2020/06/10/governor-hogan-announces-next-
stage-two-reopenings-including-indoor-dining-and-outdoor-amusments/;
Governor Hogan Announces Beginning of Stage Two of Maryland’s
COVID–19 Recovery, Safe and Gradual Reopening of Workplaces and
Businesses (June 3, 2020), https://governor.maryland.gov/2020/06/03/
governor-hogan-announces-beginning-of-stage-two-of-marylands-covid-19
-recovery-safe-and-gradual-reopening-of-workplaces-and-businesses/.